Another disappointing result for Tecentriq in triple negative breast cancer

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Anti-PD(L)-1 antibodies have a mixed record in triple negative breast cancer, and the failure of Impassion-131, a first-line trial of Roche’s Tecentriq, is another black mark. Tecentriq failed to improve PFS versus paclitaxel in PD-L1-positive patients, Roche said, while a negative trend on overall survival, a secondary endpoint, was detected. The trial was not sufficiently powered to show a benefit here and the data are still immature, but the study had already been upsized and the readout delayed, suggesting that the company was struggling to tease out even a marginal benefit. Tecentriq has accelerated approval in the US as a first-line treatment of TNBC in patients with least 1% PD-L1 expression, based on the Impassion-130 trial. This was similar in design to Impassion-131, but recruited more patients and used Abraxane instead of paclitaxel as the chemo comparator. There is some suggestion that paclitaxel could have made a difference: the high dose steroid premedication required to stave off side effects has been associated with diminished efficacy of immunotherapies. Tecentriq’s success in a neoadjuvant TNBC study earlier this year arguably makes the Impassion131 failure less important, but it is clear that there is still much to be learned about the drug's role in this disease.

Roche trials in triple-negative breast cancer
Study Design Primary endpoint(s) Result
Neoadjuvant
Impassion-031 Tecentriq + Abraxane vs Abraxane pCR in PD-L1+ and all-comers Toplined positive in PD-L1+ and all-comers
Neoadjuvant + adjuvant
NeoTRIPaPDL1  Tecentriq + Abraxane vs Abraxane EFS Failed in Dec 2019
MO39875 Tecentriq + chemo vs chemo pCR & EFS Dec 2023 primary completion
Adjuvant
Impassion-030 Tecentriq + chemo vs chemo iDFS Jan 2022 primary completion
First-line
Impassion-130 Tecentriq + Abraxane vs Abraxane OS & PFS in PD-L1+ and all-comers Approved in ≥1% PD-L1
Impassion-131 Tecentriq + paclitaxel vs paclitaxel PFS in PD-L1+ and all-comers Failed in Aug 2020
Impassion-132 Tecentriq + chemo vs chemo OS in PD-L1+ and all-comers Upsized by 63%, completion delayed from Jul 2019 to Jan 2023
Ipatunity-130 Ipatasertib + chemo vs chemo PFS in PIK3CA/AKT1/PTEN-altered Dec 2021 primary completion
Source: clinicaltrials.gov & company presentation.

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